The aim of this study will be evaluated the effect of FFP and albumin in organophosphate poisoning with an approach to the plasma cholinesterase level and oxidative stress biomarkers. ]nclusion criterias included history and clinical signs of organophosphates poisoning and reduce acetyl cholinesterase level and exclusion criteria included chronic liver diseases and pregnancy. On the basis of organophosphate poisoned patients who will be admitted to farshchian sina hospital of Hamadan province of Iran; 60 patients will be selected and divided into three groups: control and two interventional groups. The control group will be underwent conventional treatments (atropine and pralidoxime), the first interventional group will be recieved conventional therapy with fresh frozen plasma and second interventional group will be recieved conventional therapy with albumin for 3 days.In the meantime, acetyl cholinesterase levels will be measured daily and finally after termination of treatment oxidative stress biomarkers will be assessed .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121131347N1
Registration date:2017-05-22, 1396/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-22, 1396/03/01
Registrant information
Name
Saeed Afzali
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 4191
Email address
afzali@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University Of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of fresh frozen plasma (FFP) and albumin on oxidative stress biomarkers in organophosphorous pesticide poisoning
Public title
The study of fresh frozen plasma (FFP) and albumin on oxidative stress biomarkers in organophosphorous pesticide poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical symptoms and signs with organophosphates poisonig ;Reduce of acetylcholine esterase level ; Age 20-40 Y
exclusion criteria:
Chronic disease Patients ; Smoking , Pregnancy and Lactation ; Admitted after 12 hour of poisoning ; Drugs (succynil choline ,phenothiazines,antihystamines)
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University Of Medical Sciences
Street address
Vice-Chancellor For Research and Technology -Mahdieh Street
City
Hamadan
Postal code
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.UMSHA.REC.1395.568
Health conditions studied
1
Description of health condition studied
Toxic effect of pesticides
ICD-10 code
T60.0
ICD-10 code description
Organophosphate and carbamate insecticides
Primary outcomes
1
Description
Acetylcholine esterase
Timepoint
Before and after treatment
Method of measurement
Blood level
Secondary outcomes
1
Description
Oxidative stress biomarker
Timepoint
After treatment
Method of measurement
Blood sample
Intervention groups
1
Description
Control group:
Convensional treatment : atropine and pralidoxime
Category
Treatment - Drugs
2
Description
First patient group:
Convensional treatment with 3 units fresh frozen plasma for 3 days
Category
Treatment - Drugs
3
Description
Second patient group:
Convensional treatment with 100 mililiters albumin 20% for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poisoning ward - Farshchian Sina Hospital
Full name of responsible person
Saeed Afzali
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdieh Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Saeed Afzali
Position
Associated Professor
Other areas of specialty/work
Street address
Poisoning Ward - Farshchian Sina Hospital-Mirzadeheshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4191
Fax
Email
http://fsh.umsha.ac.ir/
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Akram Ranjbar
Position
PHD
Other areas of specialty/work
Street address
Pharmacy Faculty - Mahdieh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1675
Fax
Email
http://pharmacy.umsha.ac.ir/
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Saeed Afzali
Position
Clinical Toxicologist
Other areas of specialty/work
Street address
Poisoning Ward , Farshchian Sina Hospital ,Mirzadeheshghi Ave.
City
Hamadan
Postal code
6516748741
Phone
+98 81 3827 4191
Fax
Email
afzali691@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)